Quality R&D Lead - Dds&Ivd

Stevanato Group; Spoleto; In loco; EUR 39.000 - 47.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive health coverage

Meal vouchers

Welfare platform access

Language training

Descrizione del lavoro

Stevanato Group is seeking a Quality R&D Lead in Milan to act as the quality reference in product development, ensuring QMS and Design Control compliance. You will drive risk-based decisions throughout development, lead design reviews, and ensure proper risk management integration.

The role requires 5–8 years in QA/R&D within medical devices, strong knowledge of ISO 13485 and 21 CFR 820, and proven collaboration across teams.

Competenze

• 5-8 years of QA/R&D experience in Medical Device or combination product environments.
• Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820).
• Solid experience with Risk Management (ISO 14971) and DHF auditing.
• Familiar with QMS and regulatory standards in medical device development.
• Excellent communication across functions and teams.

Mansioni

• Act as Quality Lead in product development projects, ensuring design control compliance.
• Support Design Team as quality and technical reference for key decisions.
• Lead quality activities across product and process development including design transfer.
• Review and approve Design Control documentation, DHF and Risk files.
• Coordinate risk assessments and lifecycle changes with stakeholders.

Conoscenze

Quality Assurance

Design Control

Risk Management

Medical Device

Cross-functional collaboration

Descrizione del lavoro

We are looking for a Quality R&D Lead to join our Quality R&D team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit.

Non si lasci sfuggire questa opportunità: si candidi rapidamente se la sua esperienza e le sue competenze corrispondono a quanto descritto di seguito.

In this role, you will act as the Quality reference within product development projects, ensuring compliance with the Quality Management System (QMS), Design Control and Risk Management principles and applicable standards and regulations. You will lead design reviews, drive risk-based decision making throughout the development lifecycle, guaranteeing the approprietness of key design control and risk management deliverables.

Key accountabilities

• Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
• Support the Design Team as quality and technical reference in key decisions.
• Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer.
• Review and approve Design Control documentation, DHF and Risk Management deliverables.
• Act as Process Owner for Design & Development procedures, templates and tools.
• Ensure correct application of procedures through training and continuous support to R&D teams.
• Ensure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities.
• Lead change impact and risk assessments, supporting change approval and lifecycle change control.
• Coordinate, Review and approve Risk Management File deliverables.
• Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.

Qualifications

• 5-8 years' experience in Quality Assurance R&D within Medical Device, Combination Product, Pharamceurical environments.
• Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
• Strong knowledge and practical application of ISO 14971 Risk Management principles and methodologies.
• Experience authoring and reviewing Risk Management Files and Design History Files
• Familiarity with QMS and applicable standards and regulations.
• Strong communication skills and ability to work cross-functionally.

Preferred Qualifications

• Experience with drug delivery systems, combination products, or complex medical devices.
• Experience integrating supplier risk assessments and external component risks into system-level risk evaluations.
• Knowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management.
• Experience participating in Notified Body and FDA inspections.

What We Offer

At Stevanato Group, we believe that great performance is sustained over time through the right combination of tools, support, wellbeing, and continuous development. As part of our offering in Italy, you will benefit from:

• Comprehensive health and protection coverage, including supplementary health insurance and life insurance
• Meal vouchers / canteen services, supporting your everyday experience at work
• Access to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices
• Continuous learning opportunities, including on-demand language training across a wide range of languages

For this role, the expected compensation range starts from € 43.000. The actual compensation will depend on a variety of job-related factors, including geographic location, professional experience, education, and skill level.

Our Commitment

At Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that potential, mindset, and motivation matter just as much as experience.